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Certified Reference Microorganisms The Simple Way to Ensure Accurate Results, Every Time Vitroids and LENTICULE ® Discs Defined CFU range and low standard deviation (ISO/IEC 17025) Fast, reliable and easy to use Expended Vitroid range Operated by Public Health England Operated by Public Health England

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Page 1: Certified Reference Microorganisms - Sigma-Aldrich · Certified Reference Microorganisms ... specify the mean number of colony forming units ... CRM10006L-10EA Enterobacter aerogenes

Certified ReferenceMicroorganismsThe Simple Way to Ensure Accurate Results, Every Time

Vitroids™ and LENTICULE® Discs• Defined CFU range and low standard deviation (ISO/IEC 17025)

• Fast, reliable and easy to use

Expended Vitroid range

Operated by Public Health EnglandOperated by Public Health England

Page 2: Certified Reference Microorganisms - Sigma-Aldrich · Certified Reference Microorganisms ... specify the mean number of colony forming units ... CRM10006L-10EA Enterobacter aerogenes

The discs contain pure cultures of bacteria, yeasts or moulds in a solid water-soluble matrix. Comprehensive certificates of analysis specify the mean number of colony forming units (CFU) per disc, details about the method used to determine the product data and the number of subcultures from the original strains, provided under licence by NCTC® and CECT®.

Single-use controls manufactured directly from cultures provided by recognised Biological Resource Centres (BRCs) such as NCTC® and CECT® mean that laboratories can be confident about the authenticity of their strains and the suitability of their quality control materials, factors that are of increasing importance as laboratories become more automated and new technologies emerge and are rapidly adopted in routine microbiology settings.

What are Vitroids™ and LENTICULE® discs?Vitroids™ and LENTICULE® discs contain viable microorganisms in a certified quantity (generally accredited according ISO/IEC 17025), produced under reproducible conditions compliant with ISO Guide 34:2009 using authenticated strains from NCTC®, NCPF® and CECT®. Consisting of pure cultures of bacteria or fungi in a solid water soluble matrix, they are stable for at least one year and are in a viable state with a shelf life of 1-3 years. The within batch variation for every product is very low (in some cases less than 4% standard deviation). Each batch is provided with a comprehensive certificate of analysis that specifies the mean number of colony forming units (CFU), an expanded uncertainty about the mean, details about the method used to determine the product data and the number of passages (subcultures) from the original strain.

Applications

• QC to assure the quality of test results (water, food, beverage, environmental etc)

• Performance testing of media acc. ISO 11133

• Validation of new methods

• Materials for proficiency testing or ring trials

• Method development

• Staff training

• Starter cultures

StabilityCertified Reference Microorganisms in this unique format are very stable and in most cases will remain so for many years at -20 °C. The numbers of CFUs do not change, the organisms need no recovery time and have no lag phase. Even a short period at ambient temperature, such as during shipment, is not an issue for product stability.

The Simple Way to Ensure Accurate Results, Every TimeCertified Reference Microorganisms

Why use CRMs in Microbiology?In food, water and environmental microbiology, laboratory results are an important part of a wider process that helps to confirm that samples are of an acceptable microbiological quality, are safe and comply with relevant legislation or guidelines. Quality control is an essential element of a laboratory’s quality assurance system and characterised authenticated reference materials are necessary for effective quality control.

The same is true of microbiological testing; the one factor that is repeatedly overlooked is careful sourcing of biological resources such as the quality control strains. Incorrect quality control materials may indicate that test results are acceptable when, in fact, there is a problem with the samples being tested. Alternatively, control results may indicate that a test is not performing correctly, instigating unnecessary investigations and repeat testing.

Ready-to-use microbiological controls minimise the need for maintaining control strains in the test laboratory and guarantee that an authenticated control culture is used for every quality control test. Such control materials must be fit-for-purpose, bearing in mind that for food, water and environmental samples the ability to accurately enumerate bacteria, yeasts and moulds and reliably detect relatively low numbers of pathogenic organisms is essential. It is also important that controls can be applied to the wide range of different food and water matrices that are often tested in a single laboratory.

The application of a unique preservation technology involving controlled-drying of authenticated cultures of internationally accepted microbiology control strains has resulted in the production of single-use discs containing microorganisms, designed for use in food, water and environmental testing laboratories. These quality control materials, LENTICULE® discs (developed by Public Health England, PHE) and Vitroids™ (developed by RTC), are now available from Sigma Aldrich, and are manufactured under conditions compliant with ISO Guide 34:2009 (General requirements for the competence of reference material producers).

sigma-aldrich.com/mibi-crm

Page 3: Certified Reference Microorganisms - Sigma-Aldrich · Certified Reference Microorganisms ... specify the mean number of colony forming units ... CRM10006L-10EA Enterobacter aerogenes

Save Time and CostsUsing Vitroids™ and LENTICULE® discs is time saving because it removes the need for preparing stock cultures. The organisms need no recovery time and no pre-enrichment step. In addition the product concentrations are designed in a range where no or only minimal dilutions are needed. The discs readily dissolve in liquid media and on agar plates resulting in easy handling and a very economical solution.

What is New Compared to Existing Reference Strain Products?Utilization of new technology has allowed us to make major improvements in the field of Microbiological Reference Materials. The main areas of development are stability, temperature resistance, adjusting the narrow defined CFU range, rehydration time and better within batch reproducibility. In addition, each disc is certified according to ISO Guide 34 and ISO/IEC 17025.

Preparation

Most solid and liquid medium or rehydration buffer can be used. Discs can be rehydrated in as little as 100 µL buffer, or in larger volumes, e.g. 100 mL medium. It is also possible to add the disc to a cooled molten medium used for pour plate techniques. The rehydration process takes approximately 10 minutes. On solid media, the disc forms a droplet that can be spread with a sterile loop. In liquid media, the disc dissolves very quickly.

Packaging

The discs are packed individually in vials. The vials have a special screw-cap with seal and contain a desiccant at the bottom or in the cap. The vials are packed in a mylar bag with a zip.

DesiccantCRM Disc

Filter Plug

Screw

Cap

Vitroids™ and Lenticules® disc packaging

StrainsLENTICULE® discs are prepared from a traceable culture obtained freeze-dried from the National Collection of Type Cultures (NCTC®) or National Collection of Pathogenic Fungi (NCPF®) and are manufactured by Sigma-Aldrich® under license and control from Public Health England.

A New PartnershipPublic Health England's NCTC® is a national BRC that preserves, maintains and regularly updates a specific collection of bacterial strains, ensuring there are no changes to physical characteristics, such as morphology and nutritional requirements, the genome and the proteome. It is one of several BRCs that provide authenticated biological reference and control strains. In addition, the PHE also developed the LENTICULE® disc that enables a laboratory to have an on demand source of a control for quantitative microbiology.

With increased worldwide demand for the accreditation of testing labs, as well as the development of fast, automated methods in microbiology, the use of Microbial Certified Reference Materials has increased substantially. With this in mind, it is an appropriate time to entrust the manufacture and distribution of these products to an ISO accredited manufacturing company such as Sigma-Aldrich, enabling the PHE organization to focus on research and development for new products to add to this portfolio. This R&D is further enhanced by an exciting project by PHE, in collaboration with the Wellcome Trust Sanger Institute (WTSI), to provide whole genome sequences using long-read technology for 3000 bacteria of clinical importance.

An integral part of this new partnership is Sigma-Aldrich’s creation of a new, dedicated manufacturing facility in Buchs, Switzerland to provide the growth and development of Certified Reference Microorganisms, both for now and for the future. It will enable more scientists worldwide to easily access the NCTC®/NCPF® CRMs through the global supply chain of Sigma-Aldrich®.

The Benefit of Combined Experience In recent years Sigma-Aldrich, in partnership with Zurich University of Applied Sciences (ZHAW), has gained a great deal of experience developing an excellent range of Certified Reference Microorganisms (CRM) called Vitroids™. The process was standardized and CRM quality improved to a level superior to today’s standard. Since 2008, knowledge has been acquired to extend production according to ISO guide 34 and certification according to ISO/IEC 17025 to the field of microbiology. With two manufacturing and development sites, one in Laramie, Wyoming U.S.A. and the new one in Buchs, Switzerland, fufills this growing demand for microbial CRMs. Combining the know-how and capabilities of Sigma-Aldrich and PHE will benefit microbiologists all over the world.

The Sigma-Aldrich facility in Buchs, Switzerland.

Vitroids™ are derived from a traceable culture obtained freeze-dried from CECT and produced according a Sigma-Aldrich patented technology. Both NCTC and CECT strains are conveniently matched to WDCM numbers and have cfu ranges that closely align with ISO 11133.

sigma-aldrich.com/mibi-crm

Page 4: Certified Reference Microorganisms - Sigma-Aldrich · Certified Reference Microorganisms ... specify the mean number of colony forming units ... CRM10006L-10EA Enterobacter aerogenes

Certified Reference Microorganisms portfolio

sigma-aldrich.com/mibi-crm

Cat. No. Species L/V* Origin Strain No. CFU Range CRM WDCM VT091112-10EA Acinetobacter baumanni V CECT® 911 50-80 X —VT091114-10EA Acinetobacter baumanni V CECT® 911 130-270 X —VT091115-10EA Acinetobacter baumanni V CECT® 911 600-1’400 X —VT000532-10EA Aspergillus brasiliensis V CECT® 2574 50-80 X 00053VT000533-10EA Aspergillus brasiliensis V CECT® 2574 80-120 X 00053RMF02275L-10EA Aspergillus brasiliensis (formerly Aspergillus niger) L NCPF®® 2275 30-120 00053VT000013-10EA Bacillus cereus V CECT® 193 80-120 X 00001CRM07464L-10EA Bacillus cereus L NCTC® 7464 30-120 X —CRM07464M-10EA Bacillus cereus L NCTC® 7464 500 - 5 x 104 X —VT000036-10EA Bacillus subtilis V CECT® 356 3’000-7’000 X 00003VT000032-10EA Bacillus subtilis V CECT® 356 50-80 X 00003RM11351Q-10EA Campylobacter jejuni L NCTC® 11351 >100 —RMF03255H-10EA Candida albicans L NCPF® 3255 2 x 104 00055RMF03255L-10EA Candida albicans L NCPF® 3255 30-120 00055VT000543-10EA Candida albicans V CECT® 1394 80-120 X 00054VT000545-10EA Candida albicans V CECT® 1394 600-1’400 X 00054VT000546-10EA Candida albicans V CECT® 1394 3’000-7’000 X 00054RM09750L-10EA Citrobacter freundii L NCTC® 9750 30-120 —VT004014-10EA Citrobacter freundii V CECT® 401 130-270 X —VT004016-10EA Citrobacter freundii V CECT® 401 3'000 - 7'000 X —CRM00506L-10EA Clostridium bifermentans L NCTC® 506 30-120 X 00079CRM13170L-10EA Clostridium perfringens L NCTC® 13170 30-120 X 00201CRM13170M-10EA Clostridium perfringens L NCTC® 13170 500 - 5 x 104 X 00201VT000082-10EA Clostridium sporogenes V CECT® 485 50-80 X 00008CRM11467L-10EA Cronobacter sakazakii L NCTC® 11467 30-120 X 00214CRM10006L-10EA Enterobacter aerogenes L NCTC® 10006 30-120 X 00175CRM10006M-10EA Enterobacter aerogenes L NCTC® 10006 500 - 5 x 104 X 00175VT001752-10EA Enterobacter aerogenes V CECT® 684 50-80 X 00175VT001753-10EA Enterobacter aerogenes V CECT® 684 80-120 X 00175VT001754-10EA Enterobacter aerogenes V CECT® 684 130-270 X 00175VT001755-10EA Enterobacter aerogenes V CECT® 684 600-1’400 X 00175VT001756-10EA Enterobacter aerogenes V CECT® 684 3’000-7’000 X 00175VT000834-10EA Enterobacter aerogenes V CECT® 194 130-270 X 00083CRM00775H-10EA Enterococcus faecalis L NCTC® 775 >105 X 00009CRM00775L-10EA Enterococcus faecalis L NCTC® 775 30-120 X 00009CRM00775M-10EA Enterococcus faecalis L NCTC® 775 500 - 5 x 104 X 00009VT000095-10EA Enterococcus faecalis V CECT® 481 600-1’400 X 00009VT000092-10EA Enterococcus faecalis V CECT® 481 50-80 X 00009VT000093-10EA Enterococcus faecalis V CECT® 481 80-120 X 00009VT000094-10EA Enterococcus faecalis V CECT® 481 130-270 X 00009VT000096-10EA Enterococcus faecalis V CECT® 481 3’000-7’000 X 00009VT000102-10EA Enterococcus faecium V CECT® 410 50-80 X 00010VT000104-10EA Enterococcus faecium V CECT® 410 130-270 X 00010VT000105-10EA Enterococcus faecium V CECT® 410 600-1’400 X 00010CRM13216L-10EA Escherichia coli L NCTC® 13216 30-120 X 00202CRM09001H-10EA Escherichia coli L NCTC® 9001 >105 X 00090CRM09001L-10EA Escherichia coli L NCTC® 9001 30-120 X 00090CRM09001M-10EA Escherichia coli L NCTC® 9001 500 - 5 x 104 X 00090VT000133-10EA Escherichia Coli V CECT® 434 80-120 X 00013VT000902-10EA Escherichia coli V CECT® 515 50-80 X 00090VT000904-10EA Escherichia coli V CECT® 515 130-270 X 00090VT000905-10EA Escherichia coli V CECT® 515 600-1’400 X 00090VT000906-10EA Escherichia coli V CECT® 515 3’000-7’000 X 00090VT000909-10EA Escherichia coli V CECT® 515 Variable X 00090VT000902-10EA Escherichia coli V CECT® 515 50-80 X 00090VT000136-10EA Escherichia coli V CECT® 434 3’000-7’000 X 00013VT000122-10EA Escherichia coli V CECT® 516 50-80 X 00012VT000127-10EA Escherichia coli V CECT® 516 50’000-150’000 X 00012CRM12900L-10EA Escherichia coli O157 (NT) L NCTC® 12900 30-120 X 00014VT072766-10EA Fluoribacer bozemanae V CECT® 7276 3’000-7’000 X —VT072767-10EA Fluoribacer bozemanae V CECT® 7276 50’000-150’000 X —CRM08167L-10EA Klebsiella oxytoca L NCTC® 8167 30-120 X —VT000971-10EA Klebsiella pneumoniae V CECT® 143 15-40 X 00097

* L for Lenticule® technology products ; V for Vitroids™ technology products.

Page 5: Certified Reference Microorganisms - Sigma-Aldrich · Certified Reference Microorganisms ... specify the mean number of colony forming units ... CRM10006L-10EA Enterobacter aerogenes

Certified Reference Microorganisms portfolio

Negative Controls

sigma-aldrich.com/mibi-crm

Cat. No. Species L/V* Origin Strain No. CFU Range CRM WDCM VT000975-10EA Klebsiella pneumoniae V CECT® 143 600-1’400 X 00097CRM11368M-10EA Legionella bozemanii L NCTC® 11368 500 - 5 x 104 X —CRM11371M-10EA Legionella micdadei L NCTC® 11371 500 - 5 x 104 X —VT001077-10EA Legionella pneumophila V CECT® 7109 50’000-150’000 X 00107CRM12821L-10EA Legionella pneumophila L NCTC® 12821 30-120 X 00205CRM12821M-10EA Legionella pneumophila L NCTC® 12821 500 - 5 x 104 X 00205VT002057-10EA Legionella pneumophila (serogroup 1) V CECT® 8734 50’000-150’000 X 00205CRM11288L-10EA Listeria innocua L NCTC® 11288 30-120 X 00017CRM11994L-10EA Listeria monocytogenes L NCTC® 11994 30-120 X 00019CRM11994M-10EA Listeria monocytogenes L NCTC® 11994 500 - 5 x 104 X 00019VT004835-10EA Proteus hauseri V CECT® 484 600-1’400 X —VT000233-10EA Proteus mirabilis V CECT® 4168 80-120 X —VT000237-10EA Proteus mirabilis V CECT® 4168 50’000-150’000 X —CRM10662L-10EA Pseudomonas aeruginosa L NCTC® 10662 30-120 X 00114CRM10662M-10EA Pseudomonas aeruginosa L NCTC® 10662 500 - 5 x 104 X 00114VT000244-10EA Pseudomonas aeruginosa V CECT® 110 130-270 X 00024VT000249-10EA Pseudomonas aeruginosa V CECT® 110 variable X 00024VT001142-10EA Pseudomonas aeruginosa V CECT® 118 50-80 X 00025VT001143-10EA Pseudomonas aeruginosa V CECT® 118 80-120 X 00025VT001145-10EA Pseudomonas aeruginosa V CECT® 118 600-1’400 X 00025VT000261-10EA Pseudomonas aeruginosa V CECT® 111 15 - 40 X 00026VT000262-10EA Pseudomonas aeruginosa V CECT® 111 50-80 X 00026VT000262-10EA Pseudomonas aeruginosa V CECT® 111 50-80 X 00026VT000263-10EA Pseudomonas aeruginosa V CECT® 111 80-120 X 00026VT000264-10EA Pseudomonas aeruginosa V CECT® 111 130-270 X 00026VT000265-10EA Pseudomonas aeruginosa V CECT® 111 600-1’400 X 00026VT000266-10EA Pseudomonas aeruginosa V CECT® 111 3’000-7’000 X 00026VT000267-10EA Pseudomonas aeruginosa V CECT® 111 50'000-150'000 X 00026CRM09528L-10EA Raoultella planticola (formerly Klebsiella aerogenes) L NCTC® 9528 30-120 X —CRM09528M-10EA Raoultella planticola (formerly Klebsiella aerogenes) L NCTC® 9528 500 - 5 x 104 X —RMF03191M-10EA Saccharomyces cerevisiae  L NCPF® 3191 500 - 5 x 104 —RMF03191L-10EA Saccharomyces cerevisiae  L NCPF® 3191 30-120 —VT000312-10EA Salmonella enterica subsp. Enterica serovar Typhimurium V CECT® 4594 50-80 X 00031VT000313-10EA Salmonella enterica subsp. Enterica serovar Typhimurium V CECT® 4594 80-120 X 00031VT000292-10EA Salmonella enterica subsp. Enterica serovar Typhimurium V CECT® 545 50-80 X 00029VT000303-10EA Salmonella enterica subsp. Enterica serovar Typhimurium V CECT® 4300 80-120 X —CRM06676L-10EA Salmonella enteritidis L NCTC® 6676 30-120 X —CRM07832L-10EA Salmonella Nottingham L NCTC® 7832 30-120 X —CRM12023L-10EA Salmonella Typhimurium L NCTC® 12023 30-120 X 00031CRM06571L-10EA Staphylococcus aureus L NCTC® 6571 30-120 X 00035VT000322-10EA Staphylococcus aureus susp. Aureus V CECT® 239 50-80 X 00032VT000322-10EA Staphylococcus aureus susp. Aureus V CECT® 239 50-80 X 00032VT000323-10EA Staphylococcus aureus susp. Aureus V CECT® 239 80-120 X 00032VT000324-10EA Staphylococcus aureus susp. Aureus V CECT® 239 130-270 X 00032VT000325-10EA Staphylococcus aureus susp. Aureus V CECT® 239 600-1’400 X 00032VT000326-10EA Staphylococcus aureus susp. Aureus V CECT® 239 3’000-7’000 X 00032CRM06571M-10EA Staphylococcus aureus  L NCTC® 6571 500 - 5 x 104 X 00035CRM11047L-10EA Staphylococcus epidermidis L NCTC® 11047 30-120 X 00132RM11218Q-10EA Vibrio furnissi L NCTC® 11218 >100 00186RM10903Q-10EA Vibrio parahaemolyticus L NCTC® 10903 >100 00037RM11176L-10EA Yersinia enterocolitica L NCTC® 11176 30-120 —

Operated by Public Health England

LENTICULE® discs are manufactured by Sigma-Aldrich® under licence from Public Health England.

Operated by Public Health England

Get a FREE sample! of Vitroids™ & LENTICULE® discs*

For more information and a list of Certified Reference Microorganisms, visit sigma-aldrich.com/mibi-crm* Mention promo code SFV when placing your order.

Limit one package per product and per customer; no shipping fee.

Cat.Number DescriptionRMBLANK0-10EA Negative Control for Lenticule® discs, no growthRQC0001-10EA Negative Control for Vitroids™ discs, no growth

* L for Lenticule® technology products ; V for Vitroids™ technology products.

Page 6: Certified Reference Microorganisms - Sigma-Aldrich · Certified Reference Microorganisms ... specify the mean number of colony forming units ... CRM10006L-10EA Enterobacter aerogenes

©2016 Sigma-Aldrich Co. LLC. All rights reserved. SAFC and SIGMA-ALDRICH are trademarks of Sigma-Aldrich Co. LLC, registered in the US and other countries. Vitroids is a trademark of Sigma-Aldrich Co. LLC. CECT is a registered trademark of Universitat de Valencia. LENTICULE® discs are manufactured by Sigma-Aldrich under license from Public Health England. LENTICULE® discs are manufactured by Sigma-Aldrich under licence from Public Health England. Purchaser must determine the suitability of the product(s) for their particular use. Additional terms and conditions may apply. Please see product information on the Sigma-Aldrich website at www.sigmaaldrich.com and/or on the reverse side of the invoice or packing slip. Sigma-Aldrich Corp. is a subsidiary of Merck KGaA, Darmstadt, Germany.

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